NDC 0173-0663

EPIVIR HBV

Lamivudine

EPIVIR HBV is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Lamivudine.

• Product ID: 0173-0663_4909c2fe-d6d5-4980-80ec-8ef0ff9ed574
• NDC: 0173-0663
• Product Type: Human Prescription Drug
• Proprietary Name: EPIVIR HBV
• Generic Name: Lamivudine
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 1998-12-23
• Marketing Category: NDA / NDA
• Application Number: NDA021004
• Labeler Name: GlaxoSmithKline LLC
• Substance Name: LAMIVUDINE
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0173-0663-00

240 mL in 1 BOTTLE (0173-0663-00)

• Marketing Start Date: 1998-12-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0173-0663-00 [00173066300]

EPIVIR HBV SOLUTION

• Marketing Category: NDA
• Application Number: NDA021004
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1998-12-23

Drug Details

Active Ingredients

Ingredient	Strength
LAMIVUDINE	5 mg/mL

OpenFDA Data

• SPL SET ID: 2df7349c-f5d7-47b5-d29b-1b6b31985591
• Manufacturer:
  • GlaxoSmithKline LLC
• UNII:
  • 2T8Q726O95
• RxNorm Concept Unique ID - RxCUI:
  • 242692
  • 213483
  • 213484
  • 205328
• UPC Code:
  • 0301730662002

Pharmacological Class

• Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Nucleoside Analog [EXT]
• Nucleoside Reverse Transcriptase Inhibitors [MoA]

NDC Crossover Matching brand name "EPIVIR HBV" or generic name "Lamivudine"

NDC	Brand Name	Generic Name
53808-0893	EPIVIR HBV	EPIVIR HBV
0173-0662	EPIVIR	lamivudine
0173-0663	EPIVIR	lamivudine
21695-367	EPIVIR	lamivudine
49702-203	EPIVIR	lamivudine
49702-204	EPIVIR	lamivudine
49702-205	EPIVIR	lamivudine
50090-0550	EPIVIR	lamivudine
0904-6583	LAMIVUDINE	lamivudine
10135-605	Lamivudine	Lamivudine
31722-001	lamivudine	lamivudine
31722-752	Lamivudine	Lamivudine
31722-753	Lamivudine	Lamivudine
31722-754	Lamivudine	Lamivudine
33342-001	Lamivudine	Lamivudine
33342-002	Lamivudine	Lamivudine